A Positive Diagnostic Strategy Is Noninferior to a Strategy of Exclusion for Patients With Irritable Bowel Syndrome

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Abstract

BACKGROUND & AIMS: Guidelines recommend a positive strategy based on symptom criteria to diagnose patients with irritable bowel syndrome (IBS). We conducted a randomized noninferiority trial to determine whether a positive diagnostic strategy is noninferior to a strategy of exclusion, with regard to patients' health-related quality of life (HRQOL). METHODS: We studied 302 patients (18-50 years old) from primary care who were suspected of having IBS and referred by general practitioners. Patients who fulfilled the Rome III criteria for IBS with no alarm signals were randomly assigned to groups assessed by a strategy of exclusion (analyses of blood, stool samples for intestinal parasites, and sigmoidoscopies with biopsies) or a positive strategy (analyses of blood cell count and C-reactive protein). Patients were followed for 1 year. The primary end point was difference in change of HRQOL from baseline to 1 year between groups (on the basis of the Short Form 36 health survey, physical component summary, and noninferiority margin of 3 points). Secondary outcomes were change in gastrointestinal symptoms, satisfaction with management, and use of resources. Findings of diagnostic misclassification were registered. RESULTS: A positive strategy was noninferior to a strategy of exclusion (difference, 0.64; 95% confidence interval, -2.74 to 1.45). The positive diagnostic strategy had lower direct costs. Each approach had similar effects on symptoms, satisfaction, and subsequent use of health resources. No cases of inflammatory bowel disease, colorectal cancer, or celiac disease were found. CONCLUSIONS: In diagnosing IBS in primary care, use of a positive diagnostic strategy is noninferior to using a strategy of exclusion with regard to the patients' HRQOL. Our findings support the current guideline recommendations. ClinicalTrials.gov, Number NCT00659763 and NCT01153295.
Original languageEnglish
JournalClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
Volume11
Issue number8
Pages (from-to)956-962
ISSN1542-3565
DOIs
Publication statusPublished - 2013

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Irritable Bowel Syndrome
Quality of Life
Primary Health Care
Guidelines
Sigmoidoscopy
Health Resources
Celiac Disease
Health Surveys
Inflammatory Bowel Diseases
General Practitioners
Colorectal Neoplasms
Parasites
Confidence Intervals

Cite this

@article{750dbfbfb6ca41b09c5d9092f3522b50,
title = "A Positive Diagnostic Strategy Is Noninferior to a Strategy of Exclusion for Patients With Irritable Bowel Syndrome",
abstract = "BACKGROUND & AIMS: Guidelines recommend a positive strategy based on symptom criteria to diagnose patients with irritable bowel syndrome (IBS). We conducted a randomized noninferiority trial to determine whether a positive diagnostic strategy is noninferior to a strategy of exclusion, with regard to patients' health-related quality of life (HRQOL). METHODS: We studied 302 patients (18-50 years old) from primary care who were suspected of having IBS and referred by general practitioners. Patients who fulfilled the Rome III criteria for IBS with no alarm signals were randomly assigned to groups assessed by a strategy of exclusion (analyses of blood, stool samples for intestinal parasites, and sigmoidoscopies with biopsies) or a positive strategy (analyses of blood cell count and C-reactive protein). Patients were followed for 1 year. The primary end point was difference in change of HRQOL from baseline to 1 year between groups (on the basis of the Short Form 36 health survey, physical component summary, and noninferiority margin of 3 points). Secondary outcomes were change in gastrointestinal symptoms, satisfaction with management, and use of resources. Findings of diagnostic misclassification were registered. RESULTS: A positive strategy was noninferior to a strategy of exclusion (difference, 0.64; 95{\%} confidence interval, -2.74 to 1.45). The positive diagnostic strategy had lower direct costs. Each approach had similar effects on symptoms, satisfaction, and subsequent use of health resources. No cases of inflammatory bowel disease, colorectal cancer, or celiac disease were found. CONCLUSIONS: In diagnosing IBS in primary care, use of a positive diagnostic strategy is noninferior to using a strategy of exclusion with regard to the patients' HRQOL. Our findings support the current guideline recommendations. ClinicalTrials.gov, Number NCT00659763 and NCT01153295.",
author = "Begtrup, {Luise M} and Engsbro, {Anne Line} and Jens Kjeldsen and Larsen, {Pia V} and {Schaffalitzky de Muckadell}, Ove and Peter Bytzer and Jarb{\o}l, {Dorte E}",
note = "Copyright {\circledC} 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.",
year = "2013",
doi = "10.1016/j.cgh.2012.12.038",
language = "English",
volume = "11",
pages = "956--962",
journal = "Clinical Gastroenterology and Hepatology",
issn = "1542-3565",
publisher = "W.B.Saunders Co.",
number = "8",

}

TY - JOUR

T1 - A Positive Diagnostic Strategy Is Noninferior to a Strategy of Exclusion for Patients With Irritable Bowel Syndrome

AU - Begtrup, Luise M

AU - Engsbro, Anne Line

AU - Kjeldsen, Jens

AU - Larsen, Pia V

AU - Schaffalitzky de Muckadell, Ove

AU - Bytzer, Peter

AU - Jarbøl, Dorte E

N1 - Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.

PY - 2013

Y1 - 2013

N2 - BACKGROUND & AIMS: Guidelines recommend a positive strategy based on symptom criteria to diagnose patients with irritable bowel syndrome (IBS). We conducted a randomized noninferiority trial to determine whether a positive diagnostic strategy is noninferior to a strategy of exclusion, with regard to patients' health-related quality of life (HRQOL). METHODS: We studied 302 patients (18-50 years old) from primary care who were suspected of having IBS and referred by general practitioners. Patients who fulfilled the Rome III criteria for IBS with no alarm signals were randomly assigned to groups assessed by a strategy of exclusion (analyses of blood, stool samples for intestinal parasites, and sigmoidoscopies with biopsies) or a positive strategy (analyses of blood cell count and C-reactive protein). Patients were followed for 1 year. The primary end point was difference in change of HRQOL from baseline to 1 year between groups (on the basis of the Short Form 36 health survey, physical component summary, and noninferiority margin of 3 points). Secondary outcomes were change in gastrointestinal symptoms, satisfaction with management, and use of resources. Findings of diagnostic misclassification were registered. RESULTS: A positive strategy was noninferior to a strategy of exclusion (difference, 0.64; 95% confidence interval, -2.74 to 1.45). The positive diagnostic strategy had lower direct costs. Each approach had similar effects on symptoms, satisfaction, and subsequent use of health resources. No cases of inflammatory bowel disease, colorectal cancer, or celiac disease were found. CONCLUSIONS: In diagnosing IBS in primary care, use of a positive diagnostic strategy is noninferior to using a strategy of exclusion with regard to the patients' HRQOL. Our findings support the current guideline recommendations. ClinicalTrials.gov, Number NCT00659763 and NCT01153295.

AB - BACKGROUND & AIMS: Guidelines recommend a positive strategy based on symptom criteria to diagnose patients with irritable bowel syndrome (IBS). We conducted a randomized noninferiority trial to determine whether a positive diagnostic strategy is noninferior to a strategy of exclusion, with regard to patients' health-related quality of life (HRQOL). METHODS: We studied 302 patients (18-50 years old) from primary care who were suspected of having IBS and referred by general practitioners. Patients who fulfilled the Rome III criteria for IBS with no alarm signals were randomly assigned to groups assessed by a strategy of exclusion (analyses of blood, stool samples for intestinal parasites, and sigmoidoscopies with biopsies) or a positive strategy (analyses of blood cell count and C-reactive protein). Patients were followed for 1 year. The primary end point was difference in change of HRQOL from baseline to 1 year between groups (on the basis of the Short Form 36 health survey, physical component summary, and noninferiority margin of 3 points). Secondary outcomes were change in gastrointestinal symptoms, satisfaction with management, and use of resources. Findings of diagnostic misclassification were registered. RESULTS: A positive strategy was noninferior to a strategy of exclusion (difference, 0.64; 95% confidence interval, -2.74 to 1.45). The positive diagnostic strategy had lower direct costs. Each approach had similar effects on symptoms, satisfaction, and subsequent use of health resources. No cases of inflammatory bowel disease, colorectal cancer, or celiac disease were found. CONCLUSIONS: In diagnosing IBS in primary care, use of a positive diagnostic strategy is noninferior to using a strategy of exclusion with regard to the patients' HRQOL. Our findings support the current guideline recommendations. ClinicalTrials.gov, Number NCT00659763 and NCT01153295.

U2 - 10.1016/j.cgh.2012.12.038

DO - 10.1016/j.cgh.2012.12.038

M3 - Journal article

C2 - 23357491

VL - 11

SP - 956

EP - 962

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

SN - 1542-3565

IS - 8

ER -